Clinical trials: HER2 Positive
HER2 Positive Breast Cancer
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer.
- Trial name
- HER2CLIMB-05 (NCT05132582)
- Testing
- Tucatinib, Trastuzumab, Pertuzumab
- Where
- 307 sites in United States, Australia and 21 more
- Volunteers
- 654 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human…
- Trial name
- NCT04576455
- Testing
- Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist
- Where
- 81 sites in United States, Argentina and 15 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
Advanced ER-Positive HER2-Negative Breast Cancer
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
- Trial name
- SERENA-2 (NCT04214288)
- Testing
- AZD9833, Fulvestrant
- Where
- 85 sites in United States, Belgium and 14 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Breast Neoplasms, Breast Cancer
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
- Conditions
- Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
- Trial name
- NCT05113251
- Testing
- Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
- Where
- 145 sites in United States, Brazil and 16 more
- Volunteers
- 927 people
- Sponsor
- AstraZeneca
HER2-positive Breast Cancer
A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma.
- Trial name
- NCT03975647
- Testing
- tucatinib, T-DM1
- Where
- 490 sites in United States, Australia and 18 more
- Volunteers
- 466 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor…
- Trial name
- NCT04505826
- Testing
- OP-1250
- Where
- 19 sites in United States, Australia
- Volunteers
- 153 people
- Sponsor
- Olema Pharmaceuticals, Inc.
HER2 Positive Breast Cancer
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together.
- Trial name
- HER2CLIMB-04 (NCT04539938)
- Testing
- tucatinib, trastuzumab deruxtecan
- Where
- 140 sites in United States
- Volunteers
- 70 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
HER2-positive Early Breast Cancer
A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer
This study will evaluate the pharmacokinetics, efficacy, and safety of the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) as compared with those of the pertuzumab intravenous (IV)…
- Trial name
- NCT04024462
- Testing
- Pertuzumab IV, Trastuzumab IV, Pertuzumab and Trastuzumab FDC SC
- Where
- 18 sites in China
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer, HER2-positive Breast Cancer
Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
This is an open-label, Phase 2 study to evaluate preliminary anti-tumor activity, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BDC-1001 administered as a single agent and in…
- Trial name
- NCT05954143
- Testing
- BDC-1001, Pertuzumab
- Where
- 4 sites in United States, Spain
- Volunteers
- 11 people
- Sponsor
- Bolt Biotherapeutics, Inc.
Triple-negative Breast Cancer, Non-squamous Non-small-cell Lung Cancer
A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)
This is a study evaluating the efficacy, safety, and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumors including previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC…
- Conditions
- Triple-negative Breast Cancer, Non-squamous Non-small-cell Lung Cancer, NSCLC, Estrogen-receptor-positive Breast Cancer
- Trial name
- NCT04504916
- Testing
- Zilovertamab vedotin
- Where
- 14 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Breast Cancer, Adjuvant Therapy
A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
The purpose of this study is to describe the demographic and clinical profiles of patients with early-stage HER2+ breast cancer treated with neratinib as an extended adjuvant therapy as part of the Early Access Program (EAP) in…
- Conditions
- Breast Cancer, Adjuvant Therapy, HER2-positive Breast Cancer
- Trial name
- NEAR (NCT05599334)
- Where
- 25 sites in Belgium, Croatia and 3 more
- Volunteers
- 111 people
- Sponsor
- Pierre Fabre Medicament
Gastric Cancer, Gastroesophageal Junction Cancer
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer
- Trial name
- MAHOGANY (NCT04082364)
- Testing
- margetuximab, Retifanlimab, Tebotelimab
- Where
- 73 sites in United States, China and 7 more
- Volunteers
- 82 people
- Sponsor
- MacroGenics
HER2 Positive Gastric Cancer, Metastatic HER2 Positive Gastroesophageal Junction Cancer
TAC T-cells for the Treatment of HER2-positive Solid Tumors
TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).
- Trial name
- TACTIC-2 (NCT04727151)
- Testing
- TAC01-HER2, TAC01-HER2 plus pembrolizumab
- Where
- 11 sites in United States, Canada
- Volunteers
- 28 people
- Sponsor
- Triumvira Immunologics, Inc.
Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer
This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients…
- Trial name
- NCT04467515
- Testing
- CAM-H2
- Where
- 12 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Precirix
Advanced Solid Tumors, Metastatic Colon Cancer
A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers
An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
- Conditions
- Advanced Solid Tumors, Metastatic Colon Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
- Trial name
- NCT03251378
- Testing
- Fruquintinib (HMPL-013)
- Where
- 9 sites in United States
- Volunteers
- 129 people
- Sponsor
- Hutchison Medipharma Limited
HER2-positive Breast Cancer
Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer
This study was a phase III, multicenter, triple-blind, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to originator pertuzumab in HER2-positive early breast…
- Trial name
- NCT04957212
- Testing
- Trastuzumab, Pertuzumab, Carboplatin
- Where
- 44 sites in Iran
- Volunteers
- 214 people
- Sponsor
- Cinnagen
HER2-Positive Early Breast Cancer
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical…
- Trial name
- PHranceSCa (NCT03674112)
- Testing
- Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC), Pertuzumab IV, Trastuzumab IV
- Where
- 40 sites in United States, Argentina and 15 more
- Volunteers
- 160 people
- Sponsor
- Hoffmann-La Roche
HER2 Positive Breast Cancer
A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma.
- Trial name
- HER2CLIMB (NCT02614794)
- Testing
- tucatinib, capecitabine, trastuzumab
- Where
- 176 sites in United States, Australia and 13 more
- Volunteers
- 612 people
- Sponsor
- Seagen Inc.
HER2-positive Breast Cancer, Early-stage Breast Cancer
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and…
- Conditions
- HER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer, Breast Neoplasms
- Trial name
- NCT04109391
- Testing
- TX05 (trastuzumab), Herceptin (trastuzumab)
- Where
- 86 sites in Belarus, Chile and 8 more
- Volunteers
- 338 people
- Sponsor
- Tanvex BioPharma USA, Inc.
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2).
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Trial name
- NCT05091528
- Testing
- SBT6050, trastuzumab deruxtecan, tucatinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Silverback Therapeutics